Erasca
SVP Biometrics
San Diego, CA or remote
Sponsorship not specifiedDetected 68 days ago
StatisticsLeadershipCommunicationCollaborationMentoringBiostatistics
About the role
- Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide.
- Reporting to the Chief Medical Officer, the SVP Biometrics will be accountable for biometrics activities for all programs from IND-enabling to registration and launch.
Responsibilities
- Build, m aintain, and develop a high performing team across Biostatistics, Statistical Programming & Analysis, and Clinical Data Management.
- Ensure systems, capabilities and resources are in place that optimize the design, conduct, analysis and interpretation of clinical and nonclinical data for all program s.
- In collaboration with Sr Director, Clinical Data Management, provide support to clinical study teams on the collection, interpretation and reporting of clinical data.
- Provide input on key development documents, clinical protocols, study reports, IBs, INDs, NDAs, and labeling for all products.
- Review and comment on eCRFs, annotated eCRFs, edit checks documents, and other clinical data management related documents.
- Lead biometrics due diligence in support of business and corporate development activities.
- Perform all duties in keeping with the Company's core values, policies and all applicable regulations.
Requirements
- Up to 25% travel may be required, possible international travel.
Nice to have
- Minimum of 15 years relevant experience in the pharmaceutical or biotechnology industry, ideally including both large and small company experience.
- PhD degree in statistics or <span da
Skills
- This includes leadership of the Biostatistics, Statistical Programming & Analysis, and Clinical Data Management functions.
Benefits
- Represent biometrics in interactions with regulatory agencies and health authorities.
This listing is sourced directly from Erasca's careers page and normalized into a canonical job model.